Therapy Detail

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Therapy Name Sotorasib
Synonyms
Therapy Description

Lumakras (sotorasib) is small molecule inhibitor that selectively targets KRAS G12C and inhibits downstream signaling, which may lead to growth inhibition of tumors harboring KRAS G12C (PMID: 31666701). Lumakras (sotorasib) is FDA approved for use in patients with locally advanced or metastatic non-small cell lung cancer harboring KRAS G12C who have received one or more prior therapy (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Sotorasib Lumakras AMG 510|AMG510|AMG-510|Lumykras KRAS G12C inhibitor 33 Lumakras (sotorasib) is small molecule inhibitor that selectively targets KRAS G12C and inhibits downstream signaling, which may lead to growth inhibition of tumors harboring KRAS G12C (PMID: 31666701). Lumakras (sotorasib) is FDA approved for use in patients with locally advanced or metastatic non-small cell lung cancer harboring KRAS G12C who have received one or more prior therapy (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
NRAS G12C Advanced Solid Tumor sensitive Sotorasib Preclinical - Cell culture Actionable In a preclinical study, Lumakras (sotorasib) inhibited viability of cultured cells expressing NRAS G12C (PMID: 38236605). 38236605
NRAS G12C leukemia predicted - sensitive Sotorasib Preclinical - Biochemical Actionable In a preclinical study, Lumakras (sotorasib) inhibited downstream signaling in leukemia cells harboring NRAS G12C in culture (PMID: 38236605). 38236605
HRAS G12C Advanced Solid Tumor sensitive Sotorasib Preclinical - Cell culture Actionable In a preclinical study, Lumakras (sotorasib) inhibited viability of cultured cells expressing HRAS G12C (PMID: 38236605). 38236605

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT05638295 Phase II Sotorasib Panitumumab + Sotorasib Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial) Recruiting USA 0
NCT05398094 Phase II Sotorasib Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy (MERIT-lung) Recruiting ESP 0
NCT06333678 Phase II Durvalumab Sotorasib A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC) Recruiting USA 0
NCT04667234 Expanded access Sotorasib Expanded Access of Sotorasib No longer available USA 5
NCT03600883 Phase Ib/II Midazolam + Sotorasib Sotorasib + unspecified PD-1 antibody Sotorasib + unspecified PD-L1 antibody Sotorasib A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100) Active, not recruiting USA | FRA | ESP | DEU | CAN | BEL | AUT | AUS 8
NCT04303780 Phase III Sotorasib Docetaxel Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200). Active, not recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 13
NCT04185883 Phase Ib/II Fluorouracil + Irinotecan + Panitumumab + Sotorasib AMG 404 + Sotorasib Carboplatin + Docetaxel + Paclitaxel + Pembrolizumab + Pemetrexed Disodium + Sotorasib Sotorasib + TNO155 Atezolizumab + Sotorasib Pembrolizumab + Sotorasib Sotorasib Everolimus + Sotorasib Bevacizumab-awwb + Fluorouracil + Oxaliplatin + Sotorasib Bevacizumab-awwb + Fluorouracil + Irinotecan + Sotorasib BI 1701963 + Sotorasib Palbociclib + Sotorasib Afatinib + Sotorasib RMC-4630 + Sotorasib Panitumumab + Sotorasib + Trametinib Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) Recruiting USA | NLD | ITA | GBR | ESP | DEU | CAN | BEL | AUT | AUS 3
NCT04933695 Phase II Sotorasib A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment (CodeBreaK201) Active, not recruiting USA | NLD | ITA | FRA | ESP | DEU | BEL 3
NCT05631249 Phase II Sotorasib Sotorasib in Previously Treated Locally Advanced or Metastatic NSCLC Subjects With Mutated KRAS p.G12C (CODEBREAK-IGR) Recruiting FRA 0
NCT05400577 Phase II Sotorasib Sotorasib in KRAS G12C Mutated, Resectable, Stage Ib-IIIA NSCLC Withdrawn USA 0
NCT04625647 Phase II Sotorasib Testing the Use of Targeted Treatment (AMG 510) for KRAS G12C Mutated Advanced Non-squamous Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial) Recruiting USA 1


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